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| Name | Class |
|---|---|
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| The Second Hospital of Anhui Medical University | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
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To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-somatropin | Experimental | Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks. |
|
| PEG-Somatropin | Experimental | High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-somatropin | Biological | High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA) | HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HtSDSBA | HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender | 26 weeks |
| Annual height velocity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Feng | Contact | 13610794989 | fengxiaohua@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Junfen Fu, PhD | The Children's Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36034802 | Derived | Jiang Z, Chen X, Dong G, Lou Y, Zhang J, Cheng X, Pan J, Liao W, Wu J, Huang X, Jin X, Liu D, Zeng T, Zhu S, Dong Q, Luo X, Lan D, Cao L, Zhang X, Liu J, Dai M, Zhang M, Liu L, Dong J, Zhao D, Ni S, Fu J. Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study. Front Pharmacol. 2022 Aug 11;13:955809. doi: 10.3389/fphar.2022.955809. eCollection 2022. |
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| First People's Hospital of Hangzhou | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Zhejiang Provincial Hospital of TCM | OTHER |
| Central South University | OTHER |
| Southwest Hospital, China | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Shanghai Children's Medical Center | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Shaoxing Second Hospital | OTHER |
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| PEG-somatropin | Biological | Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks. |
|
Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
| 26 weeks |
| Standard Deviation Score of serum IGF-1 (IGF-1 SDS) | IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age | 26 weeks |
| Bone Maturation | Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year) | 26 weeks |
| Wuhu No.1 People's Hospital | Recruiting | Wuhu | Anhui | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | China |
|
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | China |
|
| The Third Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
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| Harbin Children's Hospital | Recruiting | Harbin | Heilongjiang | China |
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| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | China |
|
| Children's Hospital of Changchun | Recruiting | Changchun | Jilin | China |
|
| Qilu Children's Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
|
| Chengdu Women and Children's Central Hospital | Recruiting | Chengdu | Sichuan | China |
|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| The Children's Hospital ,Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| Ningbo Women and Children's Hospital | Recruiting | Ningbo | Zhejiang | China |
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| Shaoxing Second Hospital | Recruiting | Shaoxing | Zhejiang | China |
|
| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
|
| Southwest Hospital, Third Military Medical University | Recruiting | Chongqing | China |
|
| Shanghai Children's Medical Center | Recruiting | Shanghai | China |
|
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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